A kampo preparation is a pharmaceutical prepared by blending crude drugs, in which all the active ingredients are not always specifically identified. In this, a single active ingredient alone could not exhibit its effect, but some active ingredients may compositely act with each other. For securing its quality, an assay method capable of totally evaluating the whole kampo preparation is said necessary (Patent Document 1, Patent Document 2).
The assay method includes a method of total evaluation by assaying the individual ingredients, and a bioassay method of evaluating the physiological activity by the use of a biological material. The bioassay includes an in-vivo test and an in-vitro test, but the in-vivo test has many limitations regarding the test facilities and test animals, the processing capability, etc., and there are some difficulties in applying the in-vivo test to quality evaluation of kampo preparations.
On the other hand, the in-vitro test system does not require any special facilities and may give stable test results within a short period of time. Therefore, it is desired to establish a bioassay method with this system. In fact, for myostatin, a bioassay method is reported (Patent Document 3). However, for a kampo preparation that comprises a combination of crude drugs each having plural active ingredients by themselves, a suitable bioassay system could not always be found out, and the establishment of the bioassay system is desired.
For example, yokukansan, a type of kampo preparation generally has a composition mentioned below, for which, however, a suitable bioassay system is not as yet found out. For securing high quality for yokukansan, the development of the bioassay system for yokukansan is desired.
TABLE 1IngredientsAmountJP Atractylodes Lancea Rhizome4.0 gJP Poria Sclerotium4.0 gJP Cnidium Rhizoma3.0 gJP Japanese Angelica Root3.0 gJP Bupleurum Root2.0 gJP Glycyrrhiza1.5 gJP Uncaria Hook3.0 g    Patent Document 1: JP-T 2000-512621    Patent Document 2: JP-T 2001-521876    Patent Document 3: JP-T 2005-520486